Ortho VITROS 5600 Software Recall for Parameter Reset Defect
Ortho Clinical Diagnostics is recalling VITROS 5600 Integrated System software versions 3.3.3 and below because assay parameters may reset to defaults.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Ortho Clinical Diagnostics is recalling VITROS 5600 Integrated System software versions 3.3.3 and below. The recall affects 2,617 units, including 1,272 in the United States and 1,344 in foreign countries. The affected serial number range is J56000114 through J56001879.
The recall was initiated because modifications to MicroWell Qualitative Assay Parameters are not retained and may be inadvertently reset to default settings in certain circumstances. This defect could impact the accuracy of test results.
The product was distributed nationwide in the U.S. and in 24 foreign countries, including Argentina, Australia, Brazil, Canada, China, and Japan. Users of the affected software versions should contact Ortho Clinical Diagnostics for further instructions on how to resolve the issue.
The recalled product
- Product
- VITROS 5600 Integrated System Software Versions 3.3.3 and below Product Code: 6802413 Unique Identifier: 10758750002740
- Manufacturer
- Ortho Clinical Diagnostics
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Affected Serial Number Range : J56000114- J56001879
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Ortho Clinical Diagnostics under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 5 products in this recall →Related recalls
Same manufacturer · Ortho Clinical Diagnostics
See all →- HighClinical Laboratory Quality Control Device Recalled for Diluent Assembly Error
FDA (Devices) · 2024-04-03
- HighLaboratory performance verifier recalled for mismatched diluent assembly
FDA (Devices) · 2024-04-03
- HighVITROS Troponin I ES Immunodiagnostic Reagent Pack Recalled for Incorrect Wells
FDA (Devices) · 2023-08-16
- HighFDA Recalls Troponin Cardiac Test Calibrators for Potential False Negatives
FDA (Devices) · 2023-08-16
- HighOrtho Recalls VITROS Chemistry Calibrator Kit 20 for Analytical Bias
FDA (Devices) · 2023-07-19
Same hazard · software defect
See all →- HighPhilips Spectral CT Systems Recalled for Software Issues Affecting Safety
FDA (Devices) · 2026-10-14
- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- ModerateSteris HexaVue Focus Integration System Recalled for Patient Data Mismatch
FDA (Devices) · 2026-10-14
- ModerateUnited Imaging uMI 550 PET/CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
- ModeratePhilips SmartPath to MR 7700 Recalled for Incorrect DTI Export Data
FDA (Devices) · 2026-10-07
Similar recalls
- ModerateOrtho-Clinical Diagnostics Recalls VITROS 5600 Systems Due to Software Error
FDA (Devices) · 2014-08-13
- ModerateOrtho Clinical Diagnostics Recalls VITROS 5600 Integrated System Analyzers
FDA (Devices) · 2019-08-14
- ModerateOrtho VITROS 5600 System Recalled for Software Calibration Error
FDA (Devices) · 2015-01-21
- HighVITROS 5600 Diagnostic System Software Defect Prevents Quality Control Flagging
FDA (Devices) · 2024-03-13
- ModerateOrtho-Clinical Diagnostics Recalls VITROS 5600 Integrated System Software
FDA (Devices) · 2019-05-15
- HighVITROS 5600 Diagnostic System Software Defect May Cause Erroneous Lab Results
FDA (Devices) · 2024-03-13